Posted on 02/12/2005 11:32:36 AM PST by neverdem
Government scientists, concerned that two prescription creams used widely for a common skin condition may increase the risk of certain cancers, especially among children, will propose adding strong new warnings to the product labels.
A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a new Food and Drug Administration analysis.
"The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents," wrote Jean Temeck of the FDA's division of pediatric drug development in a recommendation posted late yesterday on the agency's Web site.
The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend what action the agency should take.
Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.
The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written for the creams.
The creams were approved for short-term or intermittent use by adults and children age 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively, and both creams are believed to be widely used for longer periods and among babies.
"These products are being widely used to treat . . . a non-life-threatening disease, and heavily advertised for use in young children without appreciation . . . regarding the... carcinogenic risk,"
(Excerpt) Read more at washingtonpost.com ...
where are the dead rats?
FYI ping
FReepmail me if you want on or off my health and science ping list.
A lot of them are in chicago where they vote every four years.
When since steroid creams and ointments can cause problems also, I think this is was writen by a lawyer waiting to cash in on a lawsuit.
My name is Mark, and I don't know why doctors don't have this, but I'm telling you they don't;)
"At least 5 million prescriptions have been written for the creams .... At least seven cases of lymphoma have been reported, as well as at least seven cases of skin cancer and a handful of others, Temeck wrote. Several children reported infections..So what do we have here - that is besides the authors obvious hangup with the number seven. If we add allllll the sevens, 'severals' and ' handfuls we get approximately the number 28 - out of FIVE MILLION prescriptions. That result is .0000056%!! Now if that isn't 'safe', I don't know what the heck is.
oops, gotta go, my ear itches - time to apply my Elidel
Bump.
Thanks.........I haven't been to the doctor about the eczema since I was a kid and they had no clue what the problem was. I use Benedryl when I get a bad break out and will take a Benedryl to keep me from scratching in my sleep.
You're welcome. You have mail, chicka.
Go on! Get outta here! Who ever heard of a lawyer doing that? Cheeze....
This is hearbreaking.
put me on your ping list, please.
This was the one concern we Dermatologists had when these two topicals came out. Experience from using Protopic's ingredient, tacrolimlus, orally as well as an older oral drug, cyclosporine, with the same mechanism of action gave us plenty of information on their potential side effects. Orally there were many side effects, but since they were used to prevent organ transplant rejection or for severe auto-immune diseases they were an acceptable risk for those indications. Besides they were often safer and more effective than prior treatments. Most of the side effects resulted from either direct internal effects of the drugs or were secondary to the immunosuppression they produced. As the topicals were shown to have insignificant systemic absorption, with a few rare caveats, the topicals were predicted to be free of those side effects. Time has confirmed that.
Two cancers, specifically squamous cell carcinoma of the skin and lymphomas, were problems with the oral drugs. Both cancers in such cases usually respond to treatment. Lymphomas were thought to be secondary to the immunosuppression and thus probably not a problem with the topicals. SCC is more common in many forms of immunosuppression, so could be similarly explained, but some kind of direct carcinogenic effect in the skin couldn't be ruled out without long term topical experience. Thus the topical's labelling, and we Dermatologists, have been recommending sunblock to patients using lots of these drugs. Until this piece everything I've read says the data so far showed no evidence of a cancer link. SCC and lymphoma are common cancers. Children with eczema are prone to skin infections. Useful denominators, relative risks and consideration of other possible causes in these cases would help determine whether the topicals were at fault. So far I'm underwhelmed. I suspect I'll hear more on this at our national meetings next week.
The FDA dismissal of eczema as "a non-life-threatening disease" and thus by implication as a disease unworthy of accepting any treatment related risk is worthy of contempt. As doubtless many Freepers can recall, bad eczema is a miserable condition that can ruin one's life. It can even ruin a country. Just look at how Marat, confined to his bath to obtain minimal relief from his severe eczema, shared his misery during the French revolution. For that matter eczema used to be a common cause of death via widespread secondary skin infections in the pre-antibiotic era.
Over the past couple years I believe several FDA decisions denying new drugs or restricting old ones have harmed many more Dermatology patients than these two very useful creams. Since they have become available my many eczema patients have been getting under better control and staying under better control compared to the past. Further advances, ideally a cure, are still needed. Further drugs in their class, to bid down their high prices - their real main side effect, would be nice. Generics are at least a decade away. It's hard to see how the proposed FDA actions will reduce costs.
Gawd how I hate that commercial for Zincritis or whatever it's called. Those are actors...why are they not required to say "dramatization." It is so misleading...especially the guy on the telephone.
I agree. I had a severe case beggining to build up on my hands two years ago. By December 2003 I was in an agony of itching, and the skin and flesh between my fingers on both hands was raw, and eroding away. None of the creams and lotions I was using were effective for more than a brief period, so I finally broke down and went to the doctor.
He gave me one application of his receptionists Udder Cream, with provided me with instant, blessed, long-lasting relief. Regular application of the Udder Cream controlled the itching and allowed the wounds caused by the excema to heal, though I have the scars on my fingers to this day.
We later discovered that a hyper-active thyroid is likely what brought on the dry skin conditions that allowed the excema to begin. Now that I'm under treatment for the hyper-active thyroid, my skin only goes dry and itches during the very dry conditions of winter. One or two applications of the Udder Cream a day does the job for me now.
Also, you left out the sarcasm tag to your post.
This needs to be repeated as much as possible.
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